Registration Dossier
Registration Dossier
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EC number: 260-906-9 | CAS number: 57693-14-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- EC Number:
- 260-906-9
- EC Name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- Cas Number:
- 57693-14-8
- Molecular formula:
- C40H20CrN6O14S2.3Na
- IUPAC Name:
- trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
- Preliminary study:
- No signs of toxicity nor mortality.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: none, except black discolored urine
- Gross pathology:
- no abnormal findings
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according ot the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD0 greater than 2000 mg/kg.
- Executive summary:
Method
Acute oral toxicity of test material following a single oral administration in Sprague-Dawley CD strain rats was assessed following OECD guideline 423.
Following a preliminary test in which there were no deaths at a dose level of 2000 mg/kg, an additional 4 fasted female animals were given a single oral dose of test material at a dose level of 2000 mg/kg bodyweight. The test material was administered orally as a solution in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Results
There were no deaths. Diarrhoea and urine stained black were noted during the study. Animals appeared normal two or four days after dosing. Bodyweights and weekly bodyweight changes developed normally. Necropsy findings were normal.
The acute oral median lethal dose (LD50) of the test material, in the female Sprague-Dawley CD strain rat, was estimated as being greater than 2000 mg/kg bodyweight.
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